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1 abcdefghijklm Health Department St Andrew s House Regent Road Edinburgh EH1 3DG MESSAGE TO: 1. Medical Directors of NHS Trusts 2. Directors of Public Health 3. Specialists in Pharmaceutical Public Health Telephone: Fax: Your ref: Our ref: PLW/3/8 23 July 2002 Dear Colleague FIRST PATIENT SAFETY ALERT FROM NATIONAL PATIENT SAFETY AGENCY (NPSA) Preventing accidental overdose of intravenous potassium Please find attached for onward transmission (see list below) a copy of the first patient safety alert issued by the National Patient Safety Agency (NPSA). The Minister for Health and Community Care has agreed that the Alert should be issued to NHSScotland. I also attach information about the NPSA and arrangements in Scotland. The purpose of the Alert is to reduce or eliminate incidents where a patient accidentally receives the incorrect amount of potassium through mistaken use of potassium chloride concentrate solution or other strong solutions of potassium for injection. Such incidents when they occur are frequently fatal. You may wish to revisit the policies, procedures and guidance within your Trust for potassium chloride, in the light of the actions identified for the NHS in the Alert. A patient information summary of the Alert is also attached, which can be copied and given to patients as required. 1. Please could Medical Directors in NHS Trusts forward on to: All General Practitioners, and out of hours services please ensure this message is seen by all practice nurses and non-principals working in your practice and retain a copy in your locum information pack. Trust Chief Executives Directors of Nursing Trust Chief Pharmacists Lead Consultants/Clinical Directors critical care areas Chairs of Drugs and Therapeutics Committees Risk Managers abcde abc a

2 2. Please could Directors of Public Health forward on to: Chief Executives, NHS Boards 3. Please could Specialists in Pharmaceutical Public Health forward onto: Community Pharmacists For information about the NPSA and this Alert please look at the NPSA web-site on or telephone For professional issues related to the medicine, please contact Mrs Pamela Warrington on For queries regarding the proposed agreement between NHSScotland and the NPSA you may contact Dr Alison Bramley on Thank you for your co-operation. Yours sincerely W SCOTT Chief Pharmaceutical Officer abcde abc a

3 Background to NPSA and arrangements in Scotland 1. Following the publication of Building a Safer NHS for Patients, The National Patient Safety Agency (NPSA) was established in England in July By October 2001 the NPSA had begun to build up its resources to undertake its designated functions. Role of NPSA The primary purpose of the body is to implement, operate and oversee all aspects of a national system for learning from adverse events and near misses in all sectors of the NHS 2. The National Patient Safety Agency will undertake the following key roles. the creation of a repository to collect and analyse information from clinical incidents. the assimilation of other safety related information from a variety of existing reporting systems. to learn lessons from these data and ensure they are fed back. where risks are identified, to help design solutions for the NHS. to develop an agenda for research on healthcare risk. 3. The Clinical Effectiveness Strategy Group and the Chief Medical Officer advised Ministers in August 2001 that there were significant advantages for Scotland in being part of a UK wide approach rather than establishing a separate body for Scotland alone. It is proposed that NHSScotland should establish an agreement with the National Patients Safety Agency. abcde abc a

4 recommends a safer way to use life-saving medication Patient Information 1. The National Patient Safety Agency (NPSA) has recommended that all hospitals should now take special safety measures when using a medication called potassium chloride concentrate solution. 2. NPSA has issued advice dated 23 July 2002 to all NHS hospitals and primary care services in England in the form of a Patient Safety Alert notice called Preventing Accidental Overdose with Intravenous Potassium. This advice will go to all Scottish hospitals and GP practices at the same time. 3. On the next page you will find some information so that you know what NHS hospitals and primary care services will be doing in future to increase your safety. 4. To find out more, you can look up the NPSA web-site at or telephone them on Alison Bramley Scottish Executive Health Department 23 rd July

5 The NPSA advice on the use of potassium chloride solutions in hospitals Potassium is a natural mineral which is essential for life. Too much or too little potassium in the body can cause serious illness or death. People in hospital who have too little potassium may need to have extra potassium given urgently by injection directly into a vein. Giving potassium in this way can be life-saving. It is vital that when potassium is injected into a vein it is properly mixed and that the patient gets exactly the right amount. Injecting someone with too much potassium can kill them. Potassium is supplied to hospitals in a several different forms. It comes in ready-to-use form already made up as a weak solution and also in very concentrated form as a strong solution which must usually be diluted before it is used. A few times every year, a patient accidentally gets too much potassium because a nurse or doctor mistakenly injects potassium chloride concentrate solution without diluting it enough or, by confusing it with another medicine which comes in a similar package. In order to prevent these mistakes from happening, the National Patient Safety Agency has now recommended that hospital wards and most other clinical areas should store only the ready-to-use weak solutions of potassium. The more dangerous concentrated solutions of potassium chloride should be removed from hospital wards and most other clinical areas so they don t get mixed up with other medicines which patients are having. Most hospitals in the USA accepted this safety measure about five years ago. They found that it has almost entirely stopped dangerous mistakes with strong potassium chloride solution. Some hospitals in Scotland as well as England have already introduced similar safety measure. Now all hospitals should take the same precautions. 2

6 PATIENT SAFETY ALERT PROBLEM: Research in UK and elsewhere has identified a risk to patients from errors occurring during intravenous administration of potassium solutions. Potassium chloride concentrate solution can be fatal if given inappropriately. ACTION FOR NHS BY 31 OCTOBER 2002: This alert sets out action, including initial action in the following areas: 1. Storage and handling of potassium chloride concentrate and other strong potassium solutions 2. Preparation of dilute solutions containing potassium 3. Prescription of solutions containing potassium 4. Checking use of strong potassium solutions in clinical areas For the attention of: Chief Executives of NHS Trusts and Primary Care Trusts For action by: Chief Pharmacists and pharmaceutical advisers in NHS Trusts and Primary Care Trusts For information to: Regional Directors of Health and Social Care Chief Executives of Strategic Health Authorities Directors of Public Health: Regional, StHA, PCT Medical Directors Directors of Nursing Risk Managers Lead Consultants/Clinical Directors critical care areas Communications Leads Patient Advice and Liaison Service (PALS) Date: 23 July 2002

7 Purpose of this alert The purpose of this risk alert notice is: 1. to reduce the risk of accidental overdose of intravenous potassium arising from use of potassium chloride concentrate solutions and other strong potassium solutions. (see box 1 for definition of the solutions concerned) 2. to ensure that seriously ill patients in critical care units who urgently require intravenous potassium as part of their treatment can continue to receive it promptly. Definitions Potassium chloride (KCl) concentrate solutions and other strong potassium solutions to which the same precautions should be applied Solutions of potassium chloride of concentrations 10% (1 gram potassium in 10 ml) 15% (1.5 grams potassium in 10 ml) 20% (1 gram potassium in 5ml) in ampoules and vials. Solutions of potassium hydrogen phosphate and potassium dihydrogen phosphate in ampoules and vials. Critical care areas. Intensive care units, high dependency care units, cardiac care units, other specialist critical care areas such as renal units, cardiac theatres, neonatal intensive care units and some accident and emergency departments.

8 ACTION: For NHS action by 31 October Storage and handling of potassium chloride concentrate and other strong potassium solutions 1.1 Potassium chloride concentrate solutions should be restricted to pharmacy departments and to those critical care areas where the concentrated solutions are needed for urgent use. Potassium chloride concentrate and other strong potassium solutions should be removed from routine stock in wards and clinical departments. 1.2 Potassium chloride concentrate solutions should be stored in a separate locked cupboard away from common diluting solutions such as sodium chloride (normal saline) solution. 1.3 Potassium chloride concentrate solutions should not be transferred between clinical areas. All supplies should be made directly from the pharmacy department. Documentation should follow the pattern for controlled drugs and should record the requisition, supply, receipt and administration of potassium chloride concentrate solution. 2. Preparation of dilute solutions containing potassium 2.1 Commercially prepared ready to use diluted solutions containing potassium should be used wherever possible. 2.2 Where there is a requirement for potassium solution in a dilution which is not available commercially prepared in ready to use diluted form, the solution should be prepared in the hospital pharmacy, wherever possible. 3. Prescription of solutions containing potassium 3.1 Potassium solutions for intravenous administration should generally be prescribed in those concentrations which are currently available as commercially-prepared ready to use diluted solutions. 4. Checking use of strong potassium solutions in clinical areas 4.1 A second practitioner should always check for correct product, dosage dilution, mixing and labelling during the preparation of and again prior to intravenous administration of solutions prepared from potassium chloride concentrate and other strong potassium solutions.

9 For NHS action by June Training 5.1 Risks associated with the storage, prescribing, preparation and administration of potassium chloride concentrate should be highlighted in patient safety induction training for all staff involved in the medication process and should also feature in specific training in intravenous drug preparation and administration. This includes induction schemes for locum staff. For further action by National Patient Safety Agency (NPSA) by April The NPSA will commission an audit to determine the use of potassium chloride concentrate and ready to use diluted solutions containing potassium within the NHS. This audit will identify the range of ready to use dilutions necessary to meet the full range of clinical needs. 6.2 NPSA will work with NHS Purchasing and Supply Agency, the Medicines Control Agency and the pharmaceutical industry to facilitate the manufacture and supply of an appropriate range of ready to use solutions to minimise the need for potassium chloride concentrate ampoules and vials in clinical areas. 6.3 NPSA will work with practitioners, the Medicines Control Agency and the pharmaceutical industry to determine the best method to ensure easy identification of potassium chloride concentrate and other strong potassium solutions and to implement distinctive standardised labelling and packaging of these products.

10 Background to this Patient Safety Alert IDENTIFYING AND REDUCING RISKS FROM POTASSIUM CHLORIDE CONCENTRATE SOLUTIONS Potassium chloride concentrate solution can be fatal if given inappropriately. Potassium chloride is widely used and administered intravenously in diluted solutions to treat low potassium levels (hypokalaemia) in more seriously ill patients. Patients with low potassium levels may require intravenous potassium very quickly, within minutes. A delay in administering this therapy could compromise patient care and risk cardiac arrest. Some patients in critical care settings may require potassium in the form of a very small volume of the concentrated solution. Potassium chloride concentrate ampoules can look very similar to sodium chloride, water for injection and other injectable medicines. Reports from the United States of America, Canada and the UK have identified a number of incidents where potassium chloride concentrate has been accidentally administered to patients with fatal results. A common cause of such incidents was a member of staff mistaking potassium chloride concentrate solution for sodium chloride (normal saline) solution when reconstituting a drug for injection and thereby administering to the patient an accidental overdose of potassium. These reports have prompted recommendations for safe practice from organisations in the USA, Canada and the UK. The most recent of these was a Statement on the storage and prescribing of potassium chloride concentrate injection issued by the UK Guild of Healthcare Pharmacists in December Relevant experience in USA and Canada After two years of data collection on clinical errors, it became clear to the Joint Commission for the Accreditation of Healthcare Organisations (JCAHO) in the USA that the most major category of sentinel events was medication errors and of those, the drug most frequently implicated in fatal incidents was potassium chloride concentrate. Ten incidents were reviewed in detail, where patient death occurred as a direct result of misadministration of potassium chloride concentrate. Eight of these were the result of direct infusion of potassium chloride concentrate. In all these cases, a contributing factor was the availability of potassium chloride concentrate in wards and clinical areas. In six of the eight cases, the potassium chloride concentrate was mistaken for some other medication, primarily due to similarities in packaging and labelling. Most often, the potassium chloride concentrate was mistaken for sodium chloride, heparin or furosemide (Lasix). In summary, the risk factors were: Storage of potassium chloride concentrate outside the pharmacy Extemporaneous mixing of potassium chloride concentrate in clinical areas. Requests for unusual concentrations of potassium chloride solutions. In Canada, 23 incidents were examined which took place between 1993 and 1996, and there were similar findings to those described by JCAHO. These risk factors exist despite the dangers of potassium chloride concentrate being well known. In 1997 as part of the development of their protocol, JCAHO identified through survey that potassium chloride concentrated was kept as ward stock in: 59.4% of all emergency rooms 71.9% of all intensive care units The JCAHO risk alert (1998) requires: Removal of potassium chloride concentrate from ward stock. Transfer the preparation of potassium chloride dilutions from clinical areas to the hospital pharmacy and use commercially available potassium chloride dilutions. Standardise and limit the range of potassium chloride dilutions available. JCAHO both issued a risk alert notice and amended their accreditation standards, so that all health care organisations when visited were checked for compliance. The risk alert notice was widely published, with public relations support, to ensure that front line staff understood the significance of the findings and the reason behind the changes in practice. Where there is no 24 hour access to pharmacy and it is felt necessary to keep potassium chloride concentrate in critical care areas, the JCAHO recommended protocols for the storage and use of undiluted potassium chloride

11 on care units, which have been developed in the light of scrutiny if the root cause analyses of all sentinel events, are as follows: Management in the care areas concerned should sign a liability release for the pharmacy. This acts to focus the mind of those concerned Potassium chloride concentrate ampoules and vials should be kept in amber heat sealed bags bearing the warning Must be diluted before administration Potassium chloride concentrate should be kept in a separate area in the clinical area to other ward stock medications. The controlled drug cupboard should be considered as a suitable storage location for the concentrate. The injection of potassium chloride in any situation where it is kept in concentrated form on the nursing unit should require the signatures of two nurses There has been a substantial and sustained reduction in incidents involving potassium chloride in USA following release of the JCAHO alert. Risks inherent in current control measures for potassium chloride concentrate in the NHS. NPSA commissioned a survey between March to May 2002 on arrangements for the storage and use of potassium chloride concentrate in the NHS. The main findings of the survey demonstrate that: In the overwhelming majority of hospitals in the United Kingdom undiluted potassium chloride is being stored and diluted in solutions outside pharmacy areas. The majority of hospitals have not developed local policies regarding the storage of potassium chloride concentrate or its dilution in patient care areas. The majority of United Kingdom hospitals do not have 24 hour staffing by pharmacists in order to prepare dilutions of potassium chloride outside the clinical areas. Neither critical care physicians nor pharmacists are confident that pharmacy departments in every hospital could always prepare and deliver all the required dilutions of potassium solutions to critical care areas fast enough to ensure good patient care. Further details For further details regarding this risk alert notice please contact: Dr John Shanks Director of Clinical Programmes National Patient Safety Agency Marble Arch Tower Bryanston Street LONDON W1H 7AJ Tel: /4241 Fax: website

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